Manufacturing Process (Biotechnology):

Content Related to Manufacturing Process (Biotechnology)



• 	Jan-Gunnar Gustafsson, VP of Process Development and Manufacturing, Baau Therapeutics Speaks to Pharma IQ Jan-Gunnar Gustafsson Vice President, Process Development and Manufacturing, Baau Therapeutics AB, speaks to Andrea Charles from Pharma IQ, about  contract manufacturing strategy, mitigating risk and approaches to CMO selection from a small biotech perspective, at Pharma IQ's Global
  Tags: Jan-Gunnar Gustafsson | process development | manufacturing

• 	Managing Quality Relationships with CMOs is Critical for Success In this Pharma IQ podcast, Diane Petitti, Vice President, Quality at Amylin Pharmaceuticals, speaks to Andrea Charles from Pharma IQ, about the current challenges relating to domestic and overseas outsourced manufacturing and how to determine the best CMO for your company's needs. Petitti
  Contributor:   Pharma IQ Tags: Diane Petitti | contract manufacturing | quality 09/16/2010  12:00:00 AM EDT

• GMP Guidelines Good manufacturing process (GMP) guidelines are essential to ensure drugs are produced to a consistently high quality. GMP guidelines should be implemented at all stages of the manufacturing process to eliminate the possibility of risks, that may not be detected during clinical trials. If GMP guidelines are not correctly implemented, there is a risk that poor quality and substandard pharmaceutica....Read more

  Contributor:  Pharma IQ Tags: GMP guidelines | GMP guidelines FDA | GMP guidelines food 09/06/2010  12:00:00 AM EDT

• 	Working with an Overseas CMO to Gain FDA Inspection and Approved Status Pharma IQ speaks with Earl Sullivan, Chief Executive Officer, Landela Pharmaceutical, about working with an overseas CMO to gain FDA inspection and approved status.
  Contributor:   Pharma IQ Tags: Earl Sullivan | Landela Pharmaceutical | contract manufacturing 04/21/2010  12:00:00 AM EDT

• Cost Savings Still the Number One Reason Behind 60% of Outsourced Pharma and Bio Manufacturing While there is normally more than one factor behind the decision of a pharmaceutical or biopharmaceutical organisation to outsource its global manufacturing, it seems the ever-important cost-saving potential remains among the main attraction of external production, particularly where emerging markets are concerned. The growth of global contract manufacturing A recent Pharma IQ survey conducted ....Read more

  Contributor:  Pharma IQ Tags: pharma manufacturing | pharmaceutical contract manufacturing | contract manufacturing for bio 05/17/2011  12:00:00 AM EDT

• Do's and Don’ts for Managing Pharma Contract Manufacturing Alliances Lisa Cozza, Executive Director, Manufacturing Alliances at Human Genome Sciences, joins Andrea Charles from Pharma IQ, to discuss lean manufacturing and the do's and don'ts of managing pharma contract manufacturing alliances. Pharma IQ: Lisa, what got you interested in lean manufacturing in the first place? L Cozza: I used to work for Lonza Biologics in Portsmouth, New Hampshire, a....Read more

  Contributor:  Lisa Cozza Tags: Lisa Cozza | Human Genome Sciences | lean manufacturing 09/21/2011  12:00:00 AM EDT

• What CROs and CMOs Can Learn from Q3 Outsourcing Data and 2011 Trends
  

  Nice Insights quarterly Pharmaceutical and Biotechnology Outsourcing Survey is sent to 40,000+ pharmaceutical and biotechnology executives, and with results now published for the first three quarters in 2011, interesting trends begin to emerge. In the Q3 survey report, the largest segment of respondents (29%) represented Big Pharma companies for the third consecutive quarter. This was followed close....Read more
  

  
  Contributor:  Victor Coker and Mark Allen
  Tags: CMO | CRO | outsourcing
  11/03/2011  12:00:00 AM EDT

• A Specialised Approach to Maximising Innovation for Small Biotechs and Start Ups While tremendous pricing pressure has led some companies to make deep price cuts, maintaining strong relationships and ensuring high business value from outsourcing is of great concern. In this Q&A interview, Ajit Narang, Senior Research Investigator, Drug Product Science & Technology at Bristol Myers Squibb, discusses establishing strong relationships with your outsourcing partners and key point....Read more

  Contributor:  Ajit Narang Tags: Ajit Narang | Bristol Myers Squibb | outsourcing 09/12/2011  12:00:00 AM EDT

• 	Survey: Benchmarking Your Pharmaceutical Contract Manufacturing Strategies Create your free online surveys with SurveyMonkey, the world's leading questionnaire tool. [eventpdf]....Read more
  Contributor:  Pharma IQ Surveys Tags: pharmaceutical contract manufacturing | pharma contract manufacturing survey | benckmarking contract manufacturing 04/28/2012  12:00:00 AM EDT

• 	Vendor Selection and Capacity Utilisation Rationalisation Pharma IQ interviews John Kuczek, Associate Director, Contract Manufacturing at Biogen, about vendor selection and capacity utilisation rationalisation.
  Contributor:   Pharma IQ Tags: John Kuczek | pharmaceutical contracts | drug manufacturing 04/23/2010  12:00:00 AM EDT

• Global Pharmaceutical Contract Manufacturing Soars Pharmaceutical companies are looking at global sourcing to improve their profits. North America is currently leading the overall contract manufacturing market. However, according to a recent report by RNCOS “Global Contract Manufacturing Market Analysis” , the most growth in this market has been seen in Asia in recent years. Popular pharmaceutical contract manufacturing destinations i....Read more

  Contributor:  Andrea Charles Tags: Contract Manufacturing | CMO | manufacturing 07/23/2010  12:00:00 AM EDT

• 	GSK's Peter Murray: Top Tips for Effective 3rd Party Management Peter Murray, Quality Director External Supply Strategy, GlaxoSmithKline, provides an overview of GSK's contract manufacturing strategy. In this interview with Andrea Charles from Pharma IQ, Murray discusses the drivers for external supply, CMO selection and supply chain strategy.
  Tags: Peter Murray | external supply strategy | contract manufacturing

• 	Merck Serono's Mathieu Collignon: Working with a CMO Mathieu Collignon, Associate Director CMO Marketed Products, Merck Serono, speaks to Andrea Charles from Pharma IQ, about the main challenges when working with a CMO, the importance of good communication and relationship management and being prepared for a virtual based pharmaceutical model.
  Tags: Mathieu Collignon | Merck Serono | contract manufacturing

• 5 Things You Need to Know about Continuous Pharmaceutical Manufacturing “Continuous manufacturing is done in almost all manufacturing industries, except for wine, hard spirits, and pharmaceuticals. Defining a batch is up to the manufacturer but consistent with QbD, so why don’t they do it? It means change and change only happens when there is absolute need,” said Cristina Falcão, Pharma IQ Columnist in a recent interview with Pharma IQ. Continuo....Read more

  Contributor:  Andrea Charles Tags: continuous pharmaceutical manufacturing | pharma manufacturing | continuous manufacturing 11/15/2011  12:00:00 AM EST

• Balancing Cost Pressures, Building Strong CRO Relationships Focus Philadelphia, PA - Pharma IQ, a division of IQPC, announces the 13thContract Manufacturing for Pharmaceuticals and Biotech Conference, taking place December 5 to 7, 2011 in Philadelphia, PA.   This conference program offers an in-depth look at the future of strategic CMO outsourcing, assessing risk management of quality systems, audit processes to ensure GMP, and tools to expedite supply chain ....Read more

  Contributor:  Pharma IQ News Tags: CMO | contract manufacturing | CRO 11/15/2011  12:00:00 AM EST

• Overcoming Barriers to Forming Successful Relationships with CMOs in Emerging Markets
  

  Facing an estimated loss of $14.7 billion in revenue through 2013 as a number patents for blockbuster drugs are set to expire, pharmaceutical and biotechnology companies are seeking ways to increase profitability. The various routes to grow revenue and cut fixed and variable costs are increasingly converging in emerging markets. Cost reduction efforts typically result in large markdowns of overhead &ndas....Read more
  

  
  Contributor:  Philip Rothaus
  Tags: CMO | CMOs | contract manufacturing organisations
  11/25/2011  12:00:00 AM EST

• Single Use Technologies Changing the Biomanufacturing Landscape During the past six years, single use systems and devices have emerged as a key change agent in the biomanufacturing landscape. Acceptance in R&D and scale-up has been driven by their effectiveness in reducing risks of contamination, faster changeovers, advantages over fixed stainless steel systems in cleaning and validation, and significantly reduced time, and costs to get a new facility up and....Read more

  Contributor:  Eric Langer Tags: Eric Langer | BioPlan Associates | single-use systems 04/06/2011  12:00:00 AM EDT

• Benchmarking Your Pharmaceutical Contract Manufacturing Strategies in 2013 As a thank you, all participants who complete the survey by 28th March are automatically entered in a prize draw for a free place at Pharma IQ’s 6th Annual Global Pharma Contract Manufacturing Summit. All respondents will get a copy of the results as well. Any questions don't hesitate to get in touch on enquire@iqpc.co.uk   Create your free online surveys with SurveyMonkey ,....Read more

  Contributor:  Pharma IQ Surveys Tags: pharmaceutical contract manufacturing in 2013 | 2013 CMOs | CMO 03/13/2013  12:00:00 AM EDT

• 	CMO Insight with Victor Coker Decreasing profits in pharmaceuticals over the past 5 years has put manufacturing and product costs under greater scrutiny. As a result there has been an increase in the need for a reduction in the size and cost of internal manufacturing and sourcing of cheaper products from external parties. As
  Contributor:   Andrea Charles Tags: Victor Coker | Nice Insight | CMO 06/11/2012  12:00:00 AM EDT

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